FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

Immunotherapy Trials Score Below Par in Adverse Event Reporting, According to Study

Oct. 13, 2016

Over 90 percent of clinical trials evaluating targeted cancer therapies or immunotherapies fell short in reporting adverse events in their publications — specifically in reporting recurrent or late toxicities, and detailing the duration of adverse events — according to researchers who studied 81 trials related to FDA-approved solid tumor treatments.

According to the study, 86 percent of the trials, conducted from 2000 to 2015, did not adequately report the time of adverse event occurrence, and 75 percent of trials only reported events that occurred at a frequency above a fixed threshold.

Dose reductions due to adverse events were not reported in one-third of clinical trials, the researchers said. More than half of the papers showed limitations in the method for presenting adverse events, in describing the toxicities leading to therapy withdrawal, and in the follow-up interval assessment. The study results were presented at the annual congress of the European Society for Medical Oncology in Copenhagen, Denmark.

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